[Ip-health] TWN Info: Asia wshop on patents, medicines

[Martin Khor]

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TWN Info Service on WTO Issues (Apr03/3)
www.twnside.org.sg
24 April 2003


Dear friends and colleagues

ASIA PACIFIC  WORKSHOP URGES PROPER NATIONAL POLICIES AND
LAWS TO MAXIMISE RIGHTS ON PATENTS AND MEDICINES

An Asia Pacific regional consultation was held in Colombo on 17-19 April, o=
n the WTO/TRIPS Agreement and Access to Medicines, to assist countries to f=
ormulate appropriate public policy responses.    It was attended by about 7=
0 government officials, health-related NGO representatives, health professi=
onals and international trade and IPR experts.

The meeting was organized jointly by the Health Action International - Asia=
 Pacific, the Third World Network, the Sri Lanka Ministry of Health, and th=
e World Health Organisation (South East Asia Regional Office).

The following is a summary of the main Conclusions and Recommendations of t=
he
Consultation.

The statement says that although the TRIPS Agreement has adverse effects on=
 health, it does contain several types and degrees of flexibilities that al=
low WTO Members to take certain measures to limit patent holders' exclusive=
 rights, which have been confirmed by the WTO Doha Ministerial Conference a=
nd its Declaration on TRIPS and Public Health.

The workshop discussed these flexibilities and measures, especially compuls=
ory  licensing, parallel importing and government use of patents. Legal exp=
erts at the workshop illustrated how developed countries (such as the US, t=
he UK, etc.) have for years been making use of these measures for the publi=
c purpose.

The workshop agreed that it is now vital for developing countries to make m=
aximum use of the flexibilities in TRIPS with the aim of promoting public h=
ealth. National implementation through formulating appropriate measures, po=
licies and legal provision and laws on patents is now the most important st=
ep.

The workshop also proposed many actions and measures that governments, citi=
zen groups and the WHO could undertake to bring about appropriate policies =
and measures.

For more information on the workshop, please contact:
Dr. K. Balasubramaniam (Coordinator Health
 Action International - Asia Pacific) at bala@haiap.org. or Cecilia Oh, Thi=
rd
World Network, at twnet@po.jaring.my.

Please check the Third World Network website for more information on WTO
issues:  www.twnside.org.sg.

With best wishes
Martin Khor
Cecilia Oh
Third World Network



REGIONAL CONSULTATION ON THE WTO/TRIPS AGREEMENT AND ACCESS TO MEDICINES: A=
PPROPRIATE POLICY RESPONSES
Colombo, Sri Lanka
April 17-19, 2003


SUMMARY OR THE MAIN CONCLUSIONS AND RECOMMENDATIONS


The Regional Consultation on the WTO/TRIPS Agreement and Access to Medicine=
s: Appropriate Policy Responses was held in Colombo on 17-19 April 2003.  I=
t was organized jointly by the Health Action International - Asia Pacific, =
the Third World Network, the Sri Lanka Ministry of Health, and the World He=
alth Organisation (South East Asia Regional Office). Among the 70 participa=
nts were senior health and trade officials and representatives of health-re=
lated NGOs and social movements from 18 Asian and Pacific countries, as wel=
l as international experts and resource persons.   The following is a summa=
ry of the main Conclusions and Recommendations of the Consultation, which w=
as presented at the Closing Ceremony on 19 April, to the Minister of Health=
 of Sri Lanka, who officiated at the Ceremony.


Participants at the Regional Consultation (or workshop) gathered together t=
o analyse the effects of the TRIPS Agreement on access to medicines, and to=
 discuss appropriate policy and legal responses at national, regional and i=
nternational levels.  Participants noted that  the traditional issues taken=
 up by those involved in promoting essential pharmaceutical drugs (i.e., dr=
ug efficacy, safety of drugs, saving of health expenditure through the focu=
s on essential drugs) have been overtaken in recent years by the problem of=
 public access to medicines caused by patents, especially after the WTO's T=
RIPS Agreement came into force after 2000.

TRIPS has placed constraints on WTO Members; for example, they no longer ha=
ve flexible policy space to exempt food and drugs or other sectors from pat=
entability (as they had before), and the minimum period of protection for p=
atents has been mandatorily fixed at longer terms than existed in most coun=
tries. TRIPS has tilted the balance between the IPR holder and the public i=
nterest in favour of the IPR holder, vis-=E0-vis consumers and
producers that are not IP holders. As a result, prices of drugs and other i=
tems, and the cost of production, have escalated.

Despite this adverse recent situation, participants of the workshop agreed =
that TRIPS does contain several types and degrees of flexibilities that all=
ow WTO Members to take certain measures to over-ride patent holders' exclus=
ive rights. The workshop extensively discussed these flexibilities and meas=
ures, especially compulsory licensing, parallel importing and government us=
e of patents. Legal experts at the workshop illustrated how many developed =
countries (including the US, the UK, etc.) have for years been making use o=
f these measures for the public purpose.

In relation to health, the workshop analysed the Doha Declaration on TRIPS =
and Public Health (November 2002) and noted that this Declaration has reaff=
irmed the rights of WTO Members to make use of measures like compulsory lic=
ensing and parallel imports. It has also politically and legally strengthen=
ed the ability and attitude of developing countries to make use of these me=
asures aimed at providing access to affordable medicines for all.

The workshop agreed that with the assistance of the Doha Declaration, it is=
 now vital for developing countries to make maximum use of the flexibilitie=
s in TRIPS with the aim of promoting public health. National implementation=
 through formulating appropriate measures, policies and legal provision and=
 laws on patents is now the most important step.

In this context the workshop heard the presentation on the Manual on Good P=
ractices in Public Health Sensitive Policy Measures and Patent Laws, which =
was developed by the Third World Network and a group of legal and trade exp=
erts. The participants expressed appreciation for the Manual and recommende=
d that it be widely distributed and used as an important reference, model a=
nd guide for the formulation of national policies and laws on patents and m=
edicines.

The workshop also heard and discussed presentations by legal and trade expe=
rts who explained the present situation regarding trade rules, TRIPS and th=
e use of compulsory licences, parallel imports and government use of patent=
s.

The workshop also heard from a panel of local generic drug producers in the=
 region and discussed the benefits of generic medicines in terms of the low=
 prices and good quality of such medicines. It was agreed that generic drug=
 production in the region is a viable and beneficial enterprise and should =
be spread to many countries.

During the workshop, the participants also took part in group discussions t=
hat covered the following issues: the status and situation in each country =
regarding patents, access to medicines and public health policies; obstacle=
s to taking measures like compulsory licensing and how these obstacles coul=
d be overcome; and proposals to improve the situation, including the throug=
h better regional coordination.

Taking the reports of these discussion groups into account, the workshop ha=
s
come up with the following recommendations:

1. Each country in the region should give the highest priority to formulati=
ng appropriate policies, policy measures and laws or legal provisions regar=
ding patents and access to medicines;

2. In so doing, each country should maximize the use of the rights that the=
 country has to protect and promote the health of its citizens and to provi=
de affordable medicines for all;

3. In particular, policy makers in each country should take the following
steps:

(i) limit the scope of approval of patent applications to patents that are =
genuinely novel or involve an inventive step, and to reject applications th=
at are not novel or do not satisfy the criteria of an invention, or that in=
volve only minor developments (such as slightly different dosage or formula=
tion);

(ii) examine existing legislation and determine whether there are inadequac=
ies and weaknesses, and if so, to amend these laws and introduce provisions=
 that maximize the rights  of the country to be able to adopt policy measur=
es and options such as compulsory licence, parallel imports and government =
use;

(iii) examine the national situation regarding patents and prices of medici=
ne in  relation to the diseases in the country, and devise measures such as=
 government use, compulsory licensing and parallel imports in order to effe=
ct importation or production or medicines;

(iv) examine and resolve the practical and administrative measures required=
, such as establishing institutions or competent authorities or an inter-ag=
ency committee, appropriate appeal procedures and appropriate systems and r=
ates of compensation for the patent holder;

(v) establish institutional arrangements for coordination of policies and m=
easures between different government departments involved in the issue (e.g=
., Ministry of Health, Ministry of Industry and Trade, the Patent Office, A=
ttorney-General's office or the Ministry of Law).

(vi) governments should also establish consultative mechanisms with NGOs, s=
ocial movements and private sector local generic drug producers or potentia=
l producers so that a coordinated national response can be effectively made=
;


4.  NGOs and social movements should take steps to monitor and analyse the =
developments in TRIPS (including the on-going discussions on the Paragraph =
6
issue of the Doha Declaration) and to analyse the national status and situa=
tion regarding patents and medicines, and to actively communicate their vie=
ws and proposals to the policy makers, other NGOs, the media, parliamentari=
ans, etc;

5.    A strengthened system of information sharing, communications and rese=
arch   should be established. Policy makers, NGOs, social movements, profes=
sionals, experts and generic drug producers should be part of this system. =
The organisers of the workshop (HAI AP, TWN, WHO) should discuss among them=
selves how to follow up on this proposal;

6.  The workshop participants also encouraged generic drug producers to str=
engthen their activities, to remain viable and to develop further. They sho=
uld aim to expand the production of essential and needed medicines and to m=
ake these available at the lowest possible prices. The producers should als=
o form an association or network among themselves and make known to the pub=
lic and to policy makers the capacity, expertise and services that they pos=
sess. They should also try their best to transfer technology and
production know-how to all countries in the region. They should also try to=
 make practical arrangements among the companies and with policy makers, to=
 produce, import and export generic medicines.

7.  Governments in the region should establish cooperation activities among=
 themselves, not only to share information and best practices, but also to =
establish among themselves cooperation arrangements for production, technol=
ogy-sharing, distribution, import and export of medicines, as well as the i=
ssuing of compulsory licences and other measures;

8.  The WHO has an important role to play in bringing policy makers togethe=
r to implement national and regional activities. The planned WHO activities=
 in the region, such as Ministerial Conferences should include sessions on =
patents and medicines where experts and NGOs should also be invited to pres=
ent their views. WHO should play an active and expanded role in this region=
 and also internationally;

9. We encourage and mandate the co-organisers of the workshop (HAI AP, TWN,=
 WHO) to plan follow up mechanisms, arrangements and activities. They shoul=
d consult health groups in the region, including the Peoples' Health Moveme=
nt.
These mechanisms and activities should include:

i. an information-sharing and communications system;

ii. making available a pool or team of experts on patents, trade rules and =
public health, with the perspective of health and public interest; and enco=
uraging policy makers and the WHO to make use of these experts to advise on=
 national patent laws, TRIPS negotiations, policy measures such as compulso=
ry licensing and practical actions such as generic drug production;

iii. establishing a coordinating and networking mechanism that can bring ab=
out better cooperation and activity of NGOs, policy makers and generic drug=
 producers;

10. The workshop also calls on policy makers in the region to strengthen th=
eir capacity and effectiveness in the TRIPS negotiations, including in the =
Paragraph 6 issue on TRIPS and public health, on the review of Article 27.3=
b (on biodiversity) as well as the overall review of TRIPS (under Article 7=
1.1 of TRIPS). We also call on NGOs to be active in influencing the reform =
of TRIPS. We also appreciate the endeavour of NGOs that seek to examine whe=
ther intellectual property issues should remain in the WTO and if not, then=
 what mechanisms exist for the issues to be transferred to another venue. W=
e also
appreciate the attempts by NGOs to seek alternative systems that reduce the=
 claimed rationale for monopoly and exclusive rights of patent holders (suc=
h as alternative sources of financing R&D and rewarding genuine innovation =
without having to rely on IPRs).

11. Whilst this workshop has mainly focussed on the effects and challenges =
posed by TRIPS, we are also concerned about the implications for public hea=
lth of the process and substance of bilateral and regional trade agreements=
 as well as developments in WIPO. NGOs and the generic drug producers shoul=
d actively monitor these developments and communicate their views to the go=
vernment.




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